The following data is part of a premarket notification filed by Itamar Medical with the FDA for Watch Pat 100s.
| Device ID | K042916 |
| 510k Number | K042916 |
| Device Name: | WATCH PAT 100S |
| Classification | Ventilatory Effort Recorder |
| Applicant | ITAMAR MEDICAL 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Jonathan S Kahn |
| Correspondent | Jonathan S Kahn ITAMAR MEDICAL 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-21 |
| Decision Date | 2004-12-29 |
| Summary: | summary |